IMPORTANT: PLEASE READ

PART III: CONSUMER INFORMATION What the important non-medicinal ingredients are: Sodium Chloride USP, DOXORUBICIN Water for Injection USP and Doxorubicin hydrochloride injection Hydrochloric Acid USP for pH adjustment.

This leaflet is part III of a three-part "Product What dosage form it comes in: Monograph" published when DOXORUBICIN was DOXORUBICIN injection 2 mg/mL (doxorubicin approved for sale in Canada and is designed specifically hydrochloride injection) is available in 10 mg (5mL), 50 for Consumers. This leaflet is a summary and will not mg (25mL) and 200 mg (100mL) contained in glass or tell you everything about DOXORUBICIN. Contact cytosafe (polypropylene) vials. your doctor or pharmacist if you have any questions about the drug. WARNINGS AND PRECAUTIONS

ABOUT THIS MEDICATION If you are prescribed DOXORUBICIN it will only be given to you by doctors or nurses experienced in What the medication is used for: giving chemotherapy. DOXORUBICIN is used alone and in combination with other anti-cancer medication to produce regression of If you take DOXORUBICIN you may get: tumor in several cancer conditions.  Damage to the heart muscle called heart failure. For the treatment of superficial bladder tumor, It is a decreased ability of the heart muscle to DOXORUBICIN is administered directly in the bladder. pump properly. This can lead to shortness of breath, swelling of the legs, irregular heart beat What it does: and sudden death. You are more likely to DOXORUBICIN is a chemotherapy drug, often used in develop this as the dose is increased. It may combination with other drugs to kill cancer cells. Most occur during treatment or up to several years chemotherapy agents (including DOXORUBICIN) work later. by killing rapidly dividing cells, such as cancer cells. This  Risk of new cancers. You are at increased risk action can affect normal cells as well. for getting certain blood cancers. They are When it should not be used: called acute secondary myelogenous leukemia (AML) and myelodysplastic syndrome (MDS). For intravenous administration: This can happen 1 to 3 years after treatment  Allergy to doxorubicin hydrochloride or to any with DOXORUBICIN. It is more common if ingredient in the formulation or component of the you take it at higher doses or with other cancer container of DOXORUBICIN; treatments. This risk also applies to children.  Allergy to other anthracyclines or anthracenediones such as epirubicin hydrochloride, daunorubicin  Tissue damage. DOXORUBICIN will cause hydrochloride, mitoxantrone or mitomycin C; damage if it leaks out of your vein underneath your skin. You may get blisters or sores that  Persistent low blood cell count (myelosuppression); require skin grafts. If it hurts, burns or sting in  Severe liver disease; or around the vein into which the drug is being  Severe heart disease; injected, tell the doctor or nurse  Recent heart attack; IMMEDIATELY.  Severe irregular heartbeat;  History of severe cardiac disease;  Low blood cell counts. DOXORUBICIN can  Previous treatment with maximum cumulative doses of cause a severe decrease in the number of white doxorubicin, daunorubicin, epirubicin, idarubicin and/or blood cells, red blood cells, and platelets. This other anthracyclines and anthracenediones. means that you may bruise or bleed more easily, Accumulation of anthracycline doses may be harmful go into shock and need blood transfusions.You for your heart. may get fever, serious infection, and need treatment in a hospital. Low blood cell counts For intravesical administration: can lead to death. Your doctor will check your  Blood in urine; blood cell counts during your treatment and  Urinary tract infections; after you stop it. Call your doctor right away if  Inflammation of the bladder. you get severe bleeding, fever or chills with shivering. What the medicinal ingredient is: Doxorubicin hydrochloride.  Risk of liver problems. Tell your doctor if you have a history of liver disease. You should not take DOXORUBICIN if you have a severe liver disease.

DOXORUBICIN (doxorubicin hydrochloride) Consumer Information Page 43 of 46 IMPORTANT: PLEASE READ

BEFORE you use DOXORUBICIN talk to your doctor injected through the catheter or port rather than directly or pharmacist if: into a vein.  you have low blood cell counts;  you have a liver disease; Depending on your medical condition, you may also receive DOXORUBICIN by instillation into your  you have a heart disease, recent heart attack or irregular bladder through a catheter inserted into the urinary heartbeat; natural tract.  you are taking other drugs (including calcium channel blockers) or have been previously treated with How much time does it take to get a treatment with DOXORUBICIN or other anti-cancer drugs, including DOXORUBICIN? anthracyclines (cardiotoxic drugs); It usually takes about 3-10 minutes to inject  you are pregnant, breast-feeding or planning to become DOXORUBICIN. However, you may get other pregnant. medicines before or after DOXORUBICIN, so your entire treatment may last an hour or longer.

As DOXORUBICIN may be harmful to an unborn child, If you are administered DOXORUBICIN by instillation women should be advised to avoid becoming pregnant. into your bladder, the solution should generally be Effective contraceptive methods should be used. retained in your bladder for 1-2 hours prior to voiding. As DOXORUBICIN may cause fertility impairment and damage chromosomes in sperm, men undergoing treatment How long will I need treatment? with DOXORUBICIN should use effective contraceptive Your doctor will determine the length of your treatment methods. based on your medical condition, your treatment goals, the medicines you receive, and how your body responds to those medicines. INTERACTIONS WITH THIS MEDICATION Chemotherapy is usually given in cycles that include Combination chemotherapy regimens that contain other rest periods between treatments. The rest periods give agents with similar action may lead to additive toxicity, your body a chance to build healthy new cells and especially with regard to bone marrow/hematologic, regain your strength before your next treatment. gastrointestinal, and cardiac effects. DOXORUBICIN is usually given in treatment cycles of 21 days or 28 days. You may receive 1 dose of Administration of live vaccines to immunosuppressed DOXORUBICIN every 3 or 4 weeks (on Day 1 of the patients including those undergoing cytotoxic cycle). Alternately, you may also receive chemotherapy should be avoided. DOXORUBICIN instilled into your bladder weekly for 4 weeks and then monthly. Your treatment cycle will Drug interactions with DOXORUBICIN and the following depend on your medical condition and the other drugs have been reported in the literature: chemotherapy medicines you are getting.  Paclitaxel;  Phenobarbital; Will I be able to work? Some people work full time, while others work part  Phenytoin; time or wait until their chemotherapy treatments are  Streptozocin; finished. It depends on the type of job you have and the  Cyclophosphamide; side effects you experience.  Cyclosporine  6-mercaptopurine; Is it okay to become pregnant or nurse a baby?  Actinomycin-D. No. DOXORUBICIN can be harmful to an unborn child. If there is any possibility that you may become PROPER USE OF THIS MEDICATION pregnant, ask your doctor about using birth control to prevent pregnancy during your treatment with

DOXORUBICIN. Tell your doctor right away if you How is DOXORUBICIN given? become pregnant during treatment. If you have been You may receive DOXORUBICIN through a vein in the nursing, you should stop before starting treatment with arm (“intravenously” or “IV”) by your doctor or nurse, DOXORUBICIN. Ask your baby’s doctor to usually in the hospital, outpatient department or clinic. recommend a formula that would be best for your baby.

If you are getting many injections over several weeks or months, for your convenience, your doctor may insert a catheter (thin tube) or port into a large vein in your body that is placed there as long as it is needed. Medicines get

DOXORUBICIN (doxorubicin hydrochloride) Consumer Information Page 44 of 46 IMPORTANT: PLEASE READ

What should men consider when taking SERIOUS SIDE EFFECTS, HOW OFTEN THEY DOXORUBICIN? Men undergoing treatment with doxorubicin should use HAPPEN AND WHAT TO DO ABOUT THEM effective contraceptive methods. Symptom / effect Talk with your doctor What happens after treatment? or pharmacist After you have completed all your chemotherapy Only if In all cases treatments, your doctor will check you regularly to make severe sure the cancer has not returned. Common  anorexia 

 diarrhea   Overdosage:   infection   hemorrhage    If you think you have been given more  irregular heartbeat,  DOXORUBICIN than you should, contact your chest pain, swelling  doctor, nurse, or poison control centre immediately. of the ankles,    shortness of breath /  cardiac problems  Missed Dose:  If you miss your scheduled treatment with the drug, contact  pain at the site of the injection   your doctor as soon as possible to schedule your next  rash/itch/redness/  treatment. skin allergy    SIDE EFFECTS AND 

WHAT TO DO ABOUT THEM Un-  loss of monthly  common periods 

 allergy/anaphylaxis  Like all medicines, DOXORUBICIN can have side effects.  blood clot  Common side effects include:  digestive   hair loss, which is temporary and usually starts to grow inflammation,  digestive tract back within 2 or 3 months after you have finished your  bleeding (bloody treatments. stools, bloody   increased risk of infection, as a result of low white  vomit), color blood cell count. The signs of infection include fever change of the oral  over 38°C (100°F), chills or sweating, sore throat or mucosa  coughing, redness or swelling around a cut, wound or a  dehydration  catheter site, a burning feeling when you urinate,  hot flashes  unusual vaginal itching or discharge.  shock   nausea and vomiting,  skin and nail   fatigue, or feeling tired. changes , tingling  mouth sores. sensation, urticaria  Red coloration of your urine for 1 to 2 days after administration during active therapy This is not a complete list of side effects. For any unexpected effects while taking DOXORUBICIN, Rare side effects include: contact your doctor or pharmacist.  Severe adverse events such as local tissue damages due to leakage of DOXORUBICIN from your vein into surrounding tissues with intravenous injection might HOW TO STORE IT be observed.  Damage to the heart muscle, which can cause symptoms such as shortness of breath, swelling in the DOXORUBICIN 2mg/mL shall be stored under ankles, and fluid retention. If you have these refrigeration (2-8oC), protected from light and retained symptoms, call your doctor right away. There are in carton until time of use. Discard unused solution. medicines to treat this condition.

DOXORUBICIN can cause abnormal blood test results. Your doctor will decide when to perform blood tests and will interpret the results.

DOXORUBICIN (doxorubicin hydrochloride) Consumer Information Page 45 of 46 IMPORTANT: PLEASE READ

REPORTING SUSPECTED SIDE EFFECTS

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:  Report online at: https://www.canada.ca/en/health- canada/services/drugs-health-products/medeffect- canada/adverse-reaction-reporting.html

 Call toll-free at 1-866-234-2345

 Complete a Canada Vigilance Reporting Form and:

 Fax toll-free to 1-866-678-6789, or

 Mail to: Canada Vigilance Program Health Canada Postal Locator 1908C Ottawa, Ontario K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect™ Canada Web site at https://www.canada.ca/en/health-canada/services/drugs- health-products/medeffect-canada/adverse-reaction- reporting.html NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

MORE INFORMATION

This document plus the full Product Monograph, prepared for health professionals, can be found at: http://www.pfizer.ca or by contacting the sponsor, Pfizer Canada ULC, at: 1-800-463-6001

Last revised: 5 June 2019

DOXORUBICIN (doxorubicin hydrochloride) Consumer Information Page 46 of 46